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NCT05387707 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Efficacy and Safety of Oral Difelikefalin as Adjunct Therapy to a Topical Corticosteroid for Moderate to Severe Pruritus in Subjects With Atopic Dermatitis
A Phase 3 study, sponsored by Cara Therapeutics.
- Terminated
- Registry status
- Phase 3
- Development phase
- 287
- Enrollment target
NCT05387707: Clinical Trial Phase 3 study, sponsored by Cara Therapeutics.
NCT05387707 is a Phase 3 study that was terminated before completion, run by Cara Therapeutics. The registered enrollment target is 287 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05387707, a Phase 3 study, was terminated before completion, sponsored by Cara Therapeutics.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 287 participants
- Enrollment target
Study Summary
This is a two-part, multicenter, randomized, double-blind study to evaluate the efficacy and safety of oral difelikefalin as adjunct therapy to a topical corticosteroid (TCS) for moderate-to-severe pruritus in adult subjects with atopic dermatitis (AD).
Interventions
- DRUG Placebo
- DRUG Vehicle Cream
- DRUG TCS Cream
- DRUG difelikefalin 0.25 mg
- DRUG difelikefalin 0.5 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 287 participants |
| Start Date | 2022-08-16 |
| Est. Completion | 2024-02-02 |
| Phase | Phase 3 |
Why NCT05387707 stopped before completion
NCT05387707 is an interventional study that assigns participants to a tested intervention. The registered 287 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT05387707 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05387707 about?
NCT05387707 is a clinical study titled "Study to Evaluate the Efficacy and Safety of Oral Difelikefalin as Adjunct Therapy to a Topical Corticosteroid for Moderate to Severe Pruritus in Subjects With Atopic Dermatitis". This is a two-part, multicenter, randomized, double-blind study to evaluate the efficacy and safety of oral difelikefalin as adjunct therapy to a topical corticosteroid (TCS) for moderate-to-severe pruritus in adult subjects with atopic dermatitis (AD).
What is the current status of trial NCT05387707?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 287 participants. The study started on 2022-08-16. Estimated completion is 2024-02-02.
What interventions are being tested in trial NCT05387707?
The interventions under investigation include: Placebo (DRUG), Vehicle Cream (DRUG), TCS Cream (DRUG), difelikefalin 0.25 mg (DRUG), difelikefalin 0.5 mg (DRUG).
Who is sponsoring clinical trial NCT05387707?
This trial is sponsored by Cara Therapeutics, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05387707's enrollment target sits among peer trials
287 1182nd of 2000 higher than 819 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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